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These highlights do not include all the information needed to use ELEVIDYS® safely and effectively. See full prescribing information for ELEVIDYS. ELEVIDYS (delandistrogene moxeparvovec-rokl) suspension, for intravenous infusion Initial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)]. Limitations of Use: ELEVIDYS is not recommended in patients with: Preexisting liver impairment (defined as gamma-glutamyl transferase [GGT] > 2 x upper limit of normal or total bilirubin > the upper limit of normal not due to Gilbert's syndrome) or active hepatic viral infection due to the high risk of acute serious liver injury and acute liver failure. Recent vaccination (within 4 weeks of treatment) due to immunogenicity and potential safety concerns. Active or recent (within 4 weeks) infections due to safety concerns.
- generic_name
- delandistrogene moxeparvovec-rokl
- brand_name
- isopropyl alcohol
- product_names
- delandistrogene moxeparvovec-rokl, isopropyl alcohol
- ndc
- 60923-501, 60923-501-10, 60923-562, 60923-562-01, 60923-563, 60923-502, 60923-502-11, 60923-503, 60923-503-12, 60923-504, 60923-504-13, 60923-505, 60923-505-14, 60923-506, 60923-506-15, 60923-507, 60923-507-16, 60923-508, 60923-508-17, 60923-509, 60923-509-18, 60923-510, 60923-510-19, 60923-511, 60923-511-20, 60923-512, 60923-512-21, 60923-513, 60923-513-22, 60923-514, 60923-514-23, 60923-515, 60923-515-24, 60923-516, 60923-516-25, 60923-517, 60923-517-26, 60923-518, 60923-518-27, 60923-519, 60923-519-28, 60923-520, 60923-520-29, 60923-521, 60923-521-30, 60923-522, 60923-522-31, 60923-523, 60923-523-32, 60923-524, 60923-524-33, 60923-525, 60923-525-34, 60923-526, 60923-526-35, 60923-527, 60923-527-36, 60923-528, 60923-528-37, 60923-529, 60923-529-38, 60923-530, 60923-530-39, 60923-531, 60923-531-40, 60923-532, 60923-532-41, 60923-533, 60923-533-42, 60923-534, 60923-534-43, 60923-535, 60923-535-44, 60923-536, 60923-536-45, 60923-537, 60923-537-46, 60923-538, 60923-538-47, 60923-539, 60923-539-48, 60923-540, 60923-540-49, 60923-541, 60923-541-50, 60923-542, 60923-542-51, 60923-543, 60923-543-52, 60923-544, 60923-544-53, 60923-545, 60923-545-54, 60923-546, 60923-546-55, 60923-547, 60923-547-56, 60923-548, 60923-548-57, 60923-549, 60923-549-58, 60923-550, 60923-550-59, 60923-551, 60923-551-60, 60923-552, 60923-552-61, 60923-553, 60923-553-62, 60923-554, 60923-554-63, 60923-555, 60923-555-64, 60923-556, 60923-556-65, 60923-557, 60923-557-66, 60923-558, 60923-558-67, 60923-559, 60923-559-68, 60923-560, 60923-560-69, 60923-561, 60923-561-70
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en